Question 1

Who is the manufacturer of OTOSCOPE?

Accepted Answer

Truphatek, Ltd. filed the 510(k) submission for OTOSCOPE (K902205).

Question 2

What is the FDA product code for OTOSCOPE?

Accepted Answer

ERA. It is classified under 21 CFR 874.4770 as a Class 1 device in the Ear, Nose, Throat panel.

Question 3

When was OTOSCOPE cleared by the FDA?

Accepted Answer

Aug 14, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for OTOSCOPE?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like OTOSCOPE?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K902205
Device Name	OTOSCOPE
Applicant	Truphatek, Ltd.
Product Code	ERA · Ear, Nose, Throat
Decision Date	Aug 14, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4770
Device Class	Class 1

OTOSCOPE

Device Facts

Regulatory Classification

Identification